The British Medical Journal, hardly a fringe publication, released an article on 2 November 2021 that should have been on the front page of every major national newspaper and dominated mainstream media headlines. Instead, publicity for the article has been restricted to independent media outlets, notwithstanding the massive reach of news sites such as rt.com and lifesitenews.com. What did this BMJ article say and why is it so important?
Paul Thacker, an investigative journalist for the BMJ, revealed material provided by Brook Jackson, a former Regional Director for Ventavia Research Group. This material contained evidence to support Jackson’s allegations of unsound practices during Phase III clinical trials for Pfizer’s COVID-19 vaccine product, which were conducted by Ventavia, many of which Jackson was witness to. Jackson also provides a timeline that shows reports to the FDA of these unsound practices were ignored.
This is important because the results of these Phase III clinical trials were pivotal for Pfizer to obtain an Emergency Use Authorisation for its COVID-19 vaccine product and subsequent approval.
What is Ventavia?
Ventavia (ventaviaresearch.com) claims to be the largest privately-owned clinical research company in Texas and has been in operation since 2013. It has specialist expertise in maternal vaccines, paediatrics, seniors and healthy patient trials.
Ventavia also claims to have received recognition from Pfizer for its contribution to vaccine trials for COVID-19. It is also currently recruiting volunteers for COVID-19 booster trials being conducted worldwide, to test the safety and immunogenicity of mixed boosted regimens.
Unsound Practices Reported to the FDA
Jackson is a trained clinical trial auditor with over 15 years of experience in clinical research co-ordination and management. She reported a long list of issues, “unsound practices”, to the FDA in late September 2020, regarding the way the trial she observed being run by Ventavia. Later that same day, Ventavia fired her for being “not a good fit” with the organisation, the first time she had ever been fired in a career of 20 years.
Documents shown to the BMJ included “action items” for a meeting of Ventavia leaders prior to Jackson’s tenure, where “a Ventavia executive identified three site staff members with whom to “Go over e-diary issue/falsifying data, etc.” One of them was “verbally counselled for changing data and not noting late entry””.
Photos taken by Jackson “showed needles discarded in a plastic biohazard bag instead of a sharps container box. Another showed vaccine packaging materials with trial participants’ identification numbers written on them left out in the open, potentially unblinding participants.”
The BMJ article goes on to state “In a recording of a meeting in late September2020 between Jackson and two directors a Ventavia executive can be heard explaining that the company wasn’t able to quantify the types and number of errors they were finding when examining the trial paperwork for quality control. “In my mind, it’s something new every day,” a Ventavia executive says. “We know that it’s significant.””
Adverse reaction reports were not followed up within required timeframes. Another research firm which partnered with Ventavia on the trial reported ““Subject has reported with Severe symptoms/reactions … Per protocol, subjects experiencing Grade 3 local reactions should be contacted. Please confirm if an UNPLANNED CONTACT was made and update the corresponding form as appropriate.”
Another employee of Ventavia stated of the data Ventavia generated for the Pfizer trial, “I don’t think it was good clean data…It’s a crazy mess.”
FDA Response
Jackson filed a complaint about what she had observed and documented on the Ventavia trial in September. The article states “In Pfizer’s briefing document submitted to an FDA advisory committee meeting held on 10 December 2020 to discuss Pfizer’s application for emergency use authorisation of its covid-19 vaccine, the company made no mention of problems at the Ventavia site. The next day the FDA issued the authorisation of the vaccine.” It was noted that the FDA did not inspect any of Ventavia’s sites for this pivotal Pfizer trial.
It appears that such lax oversight and lack of action is not unusual for the FDA.
Referring to another trial, Thacker wrote that “Citizens for Responsible Care and Research Incorporated (CIRCARE) and the US consumer advocacy organisation Public Citizen, along with dozens of public health experts, filed a detailed complaint in July 2018 with the FDA about a clinical trial that failed to comply with regulations for the protection of human participants. Nine months later, in April 2019, an FDA investigator inspected the clinical site. In May this year the FDA sent the triallist a warning letter that substantiated many of the claims in the complaints. It said, “[I]t appears that you did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection of human subjects.””
The full BMJ article can be found here: https://www.bmj.com/content/375/bmj.n2635
